510(k) Report

FDA applicant

Bremed Italia, S.R.L.

Arnold, MO3 decisions1997–19980 recalls

FDA records 3 decisions for Bremed Italia, S.R.L. (Arnold, MO) from 1997 to 1998: 3 510(k) clearances. All are in product code CAF (Nebulizer (Direct Patient Interface)). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Bremed Italia, S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bremed Italia, S.R.L. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bremed Italia, S.R.L. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CAFNebulizer (Direct Patient Interface)3decisions

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K974379UltranebBremed Italia, S.R.L. · 19981cites it

What has FDA decided for it lately?

  • K982043BrenebBremed Italia, S.R.L. · 1998
  • K974379UltranebBremed Italia, S.R.L. · 1998
  • K970542Master Neb IIBremed Italia, S.R.L. · 1997

All 3 as Bremed Italia, S.R.L. →